Senior Director, Global Regulatory Affairs

Job Title: Senior Director, Global Regulatory Affairs

Role Level: People Manager

Supervisor/Manager Title: Vice President, Regulatory Affairs

Job Location & Environment: Irvine, CA – Corporate Environment

Job Description Summary: Manages global regulatory affairs communication, filing strategy, regulatory negotiation and correspondence tracking, submission development, query response development and other assigned activities for all JenaValve products. Provides expertise in translating regulatory requirements into practical, workable plans. Develops and implements strategies for the earliest possible approvals of regulatory applications. Provides counsel to and manages direct report(s). Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies).

Job Responsibilities:

• Directs, manages, and oversees the Regulatory Affairs department and processes.
• Regulatory Submissions: Ensures the preparation of high-quality global filings for investigational device authorizations, product registrations, process improvements, periodic reports, and amendments/supplements. Coordinates closely with applicable regulatory authorities/agencies to ensure alignment and clarity.
• Management/Supervision: Manages RA staff and develops personnel. Creates and updates departmental procedures as required.
• Communication: Manages communication and relationships with JenaValve Leeds and Munich personnel, US and global regulators, legal agents, distributor partners, and suppliers on project­ related activities necessary to ensure appropriate regulatory approvals are in place in covered regions.
• Project Teams: Leads (or assigns) regulatory team support to product development and sustaining teams, providing clear direction and input to assure that applicable global requirements are incorporated as part of the development process and to drive attainment of company objectives.
• External Standards: Manages the company's processes to ensure all relevant external standards are identified, assessed, and interpreted, and gap analyses are documented and driven to closure.
• Marketing Materials: Reviews and approved marketing materials for compliance with labeling and regulatory requirements.
• Quality System Support: Reviews and approves risk management activities, test protocols and reports, NCRs, CAPAs, and other technical documents. Reviews and approves document change orders (DCOs) and documents the global regulatory impact.
• Adverse Event Reporting: Ensures timely, effective review of information, and reporting to regulatory authorities (e.g., Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication) and stakeholders.
• Audits: Supports internal and external audits as required.
• Produces periodic dashboards and reports on global activities, issues, recommendations, and plans going forward.
• Performs other duties as assigned by supervisor.